The complaint artegraft (collagen vascular graft) lot 15k263-027 was returned to artegraft, inc.For evaluation.The graft inner/outer diameters and length were verified as compared to the dhr release data.The thickness of the graft wall was calculated as 0.5 mm; this is well within the required acceptable range (0.25mm - 1.5mm) for the product.The customer's allegation of leaking graft pre-implant was confirmed; during the investigative pressure testing (per artegraft, inc.Process specification) bubbles were seen coming from a tributary of the graft.Additionally, 4 indents in the graft wall were observed.Possible root causes for the leaking graft may be that a ligation suture on the graft tributary loosened.The 4 indents observed in the graft wall indicate that the graft may have been mishandled during the pre-implant testing; possibly from the clamp that was applied by the surgeon during the pre-implant testing.It is also possible that too much force was applied during the pre-implant pressure test.No additional information is available regarding the tools/methods utilized by the customer for pressure testing for this incident.As this is a known issue, artegraft, inc.Instructions for use include instructions for pressure testing each graft prior to implant.Capa was previously initiated to investigate similar occurrences involving graft wall leaks pre-implant.Additional quarterly analysis of the grafts was implemented for post-sterilization data and trending.This graft was manufactured in 2015, prior to capa closure.To date, no additional complaints were reported from this product batch.The complaint issue will continue to be monitored within artegraft, inc.Quality systems, quality assurance trending.Should additional information become available, a follow-up report will be submitted.
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